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Study Protocol: Version IMPAACT P1101 Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir- Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children A Multicenter, International Trial of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) Protocol: VERSION 3.0 FINAL 24 April 20 NCT 01751568 IMPAACT P1101 Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children (DAIDS Document ID 11831) A Multicenter, International Trial of the International Maternal Pediatric Adolescent AIDS Clinical Trials Network (IMPAACT) Sponsored by: The National Institute of Allergy and Infectious Diseases (NIAID), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and the National Institute of Mental Health (NIMH) Pharmaceutical Support Provided by: Merck & Co., Inc. IND# 77,787 held by NIAID IMPAACT Treatment Scientific Committee Chair: Elaine Abrams, MD Protocol Co-Chairs: Tammy Meyers, MD Paul Krogstad, MD NIAID Medical Officer: Ellen Townley, MSN, FNP NICHD Medical Officer: Jack Moye, MD Clinical Trials Specialist: Sarah Bradford, MPH Kathleen George, MPH VERSION 3.0 FINAL 24 April 2017 PROTOCOL SIGNATURE PAGE IMPAACT P1101 Phase I/II Dose-finding, Safety, Tolerance and Pharmacokinetics Study of a Raltegravir-Containing Antiretroviral Therapy (ART) Regimen in HIV-infected and TB Co-infected Infants and Children DAIDS Document ID 11831 Version 3.0, dated 24 April 2017 I will conduct this study in accordance with the provisions of this protocol and all applicable protocol- related documents. I agree to conduct this study in compliance with United States (US) Health and Human Service regulations (45 CFR 46); applicable US Food and Drug Administration regulations; standards of the International Conference on Harmonization Guideline for Good Clinical Practice (E6); Institutional Review Board/Ethics Committee determinations; all applicable in-country, state, and local laws and regulations; and other applicable requirements (e.g., US National Institutes of Health, Division of AIDS) and institutional policies. __ Signature of Investigator of Record Date Name of Investigator of Record (printed) IMPAACT P1101 ii 24 April 2017 FINAL Version 3.0 IMPAACT P1101 PROTOCOL TEAM ROSTER Protocol Co-Chairs Kathleen George, MPH Tammy Meyers, MD FHI 360 1702 Block 82 359 Blackwell Street, Suite 200 Bamboo Grove Durham, NC 27701 74-86 Kennedy Road Phone: (919) 544-7040 x11150 Wan Chai Email: [email protected] Hong Kong People’s Republic of China Protocol Senior Statistician Phone: +852 2812 6121 Pearl Samson, MS Email: [email protected] Center for Biostatistics in AIDS Research (CBAR), Harvard T.H. Chan School of Public Paul Krogstad, MD Health/Frontier Science & Technology Research David Geffen School of Medicine at UCLA Foundation (FSTRF) Pediatrics Room 22-442 MDCC M.C. 175217 1371 Beacon Street, Suite 203 10833 Le Conte Avenue Brookline MA 02446 Los Angeles CA 90095-1752 Phone: (617) 632-2000 x4030 Phone: (310) 825-5235 Email: [email protected] Email: [email protected] Protocol Data Managers NIAID Medical Officer Linda Marillo, BA Ellen Townley, MSN, FNP Frontier Science & Technology Research DAIDS/NIAID/NIH Foundation 5601 Fishers Lane, 8B17 4033 Maple Road Rockville, MD 20852 Amherst, NY 14226-1056 Phone: (240) 292-4784 Phone: (716) 834-0900 x7257 Email: [email protected] Email: [email protected] NICHD Medical Officer Protocol Pharmacist Jack Moye, MD Thucuma Sise, PharmD, BCPS Maternal and Pediatric Infectious Disease Branch NIH, NIAID, DAIDS, PAB Eunice Kennedy Shriver National Institute for 5601 Fishers Lane, 9A27 Child Health and Human Development Rockville, MD 20852 National Institutes of Health Phone: (240) 292-4848 Bldg. 6710B Rm. 2146 Email: [email protected] 6710B Rockledge Drive Bethesda, MD 20817 Protocol Virologists Phone: (301) 594-8624 Grace Aldrovandi, MD Email: [email protected] IMPAACT Virology Laboratory 130 4546 Sunset Blvd, MS 51 Clinical Trials Specialists Smith Research Tower, Room 902 Sarah Bradford, MPH Los Angeles CA 90027 FHI 360 Phone: (323) 361-8501 359 Blackwell Street, Suite 200 Email: [email protected] Durham, NC 27701 Phone: (919) 544-7040 x11685 Email: [email protected] IMPAACT P1101 iii 24 April 2017 FINAL Version 3.0 IMPAACT P1101 PROTOCOL TEAM ROSTER Julie Nelson, PhD Laboratory Data Coordinator University of North Carolina at Chapel Hill Laura Hovind, BS, MS CB 7291; GSB 2163 Frontier Science & Technology Chapel Hill NC 27599 Research Foundation Phone: (919) 966-6872 4033 Maple Road Email: [email protected] Amherst, NY 14226 Phone: (716) 834-0900 x7468 Protocol Immunologist Email: [email protected] Savita Pahwa, MD University of Miami School of Medicine Investigators Batchelor Research Institute, Room 712 Andrew Wiznia, MD 1580 Northwest 10th Avenue Jacobi Medical Center Miami, FL 33136 1400 Pelham Parkway South Phone: (305) 243-7732 Bldg 1-1W5-8 Email: [email protected] Bronx NY 10461 Phone: (718) 918-4664 Protocol Pharmacologists Email: [email protected] Edward Acosta, PharmD Division of Clinical Pharmacology Mandar Paradkar, MBBS, DCH Department of Pharmacology and Toxicology BJ Medical College 1530 3rd Avenue South, VH 116 Pathology Museum, First Floor Jayprakash Birmingham AL 35294-0019 Narayan Road Phone: (205) 934-2655 Pune, India Email: [email protected] Phone: +91-9823457325 Email: [email protected] Laboratory Technologist Paul Harding, MS Pharmaceutical Company Representative Pediatric Infectious Diseases Hedy Teppler, MD Mail Stop 8604, Building 15 351 N. Sumneytown Pike 12700 E. 19th Avenue, Room 11460-A P.O. Box 1000 Aurora, CO 80045 North Wales, PA 19454-2505 Phone: (303) 724-3404 Phone: (267) 305-7403 Email: [email protected] Email: [email protected] Central Laboratory Specialist Carolyn Yanavich, MS, RAC IMPAACT Laboratory Center Children's Hospital of Los Angeles Smith Research Tower 4546 Sunset Blvd, Room 902 Los Angeles, CA 90027 Phone: (443) 249-3851 Fax: (323) 361-8599 Email: [email protected] IMPAACT P1101 iv 24 April 2017 FINAL Version 3.0 IMPAACT P1101 SITE INVESTIGATORS Site 8051, Shandukani Research Centre Site 8950, FAM-CRU CRS Lee Fairlie, MD Mark Cotton MMed, PhD, MBChB, NP SMACHC 2nd Floor Stellenbosch University Hillbrow Health Precinct Ward J8, Tygerberg Academic Hospital Corner Esselen St. and Klein St. Francie Van Zijl Dr., Parow Valley, 7505 Hillbrow Cape Town, South Africa Johannesburg, Gauteng 2001 Phone: +27-21-9384219 South Africa Email: [email protected] Phone: +27-11-3585317 Email: [email protected] Joan Coetzee CPN, PN Stellenbosch University Hermien Gous, PharmD Ward J8, Tygerberg Academic Hospital SMACHC 2nd Floor Francie Van Zijl Dr., Parow Valley, 7505 Hillbrow Health Precinct Cape Town, South Africa Corner Esselen St. and Klein St. Phone: +27-21-9384157 Hillbrow Email: [email protected] Johannesburg, Gauteng 2001 South Africa Site 31790: Desmond Tutu TB Centre CRS Phone: +27-11-3585502 Anneke Hesseling, MD, PhD Email: [email protected] Director, Paediatric Research Desmond Tutu TB Centre Site 8052, Soweto CRS Department of Pediatrics and Child Health Avy Violari, MD Stellenbosch University, South Africa Perinatal HIV Research Unit Phone: +27 219389173 Chris Hani Baragwanath Hospital Fax: +27 21 9389702 P.O Box 114, Diepkloof, Soweto Email: [email protected] Johannesburg Soweto 2013 Frieda Verheye-Dua, MD South Africa Desmond Tutu TB Centre Phone: +27-11-9899707 Department of Pediatrics and Child Health Email: [email protected] Stellenbosch University, South Africa Phone: +27 21 9389772 Nasreen Abrahams, MBA, BTech Fax: +27 86 689 9929 Perinatal HIV Research Unit Email: [email protected] Chris Hani Baragwanath Hospital P.O Box 114, Diepkloof, Soweto Johannesburg Soweto 2013 South Africa Phone: +27-11-9899742 Email: [email protected] IMPAACT P1101 v 24 April 2017 FINAL Version 3.0 STUDY MANAGEMENT • All questions concerning this protocol, including questions regarding clinical management of study participants, should be sent via email to the IMPAACT P1101 Protocol Team ([email protected]). Remember to include the participant’s PID when applicable. The appropriate team member will respond to questions via e-mail. A response should generally be received within 24 hours (Monday - Friday). • For protocol registration questions email [email protected] or call (301) 897-1707. Protocol registration material can be sent electronically to [email protected] or via fax at 1-800- 418-3544 or (301) 897-1701. • For data management computer and screen problems email [email protected] or call the DMC at (716) 834-0900 x7302. • For questions or problems regarding study drug supplies, records, and returns, contact the DAIDS Protocol Pharmacist at [email protected] or call (301) 451-2775. • For Expedited Adverse Event (EAE) reporting questions contact the DAIDS RSC Safety Office via email ([email protected]) or phone (1-800-537-9979 or +1-301-897- 7448) or fax (1-800-275-7619 or +1-301-897-1710). For questions about the DAIDS Adverse Experience Reporting System (DAERS), please contact NIAID CRMS Support at [email protected]. Questions may also be sent within the DAERS application. • Email the Computer Support Group at the Data Management Center (DMC) ([email protected]) to have relevant site personnel added to the protocol
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